No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Northwestern University · Other
Who this trial is looking for
This trial is looking for adults who are having lumbar surgery. Participants will receive a noninvasive treatment to see if it helps with recovery in the hospital and reduces symptoms like delirium and depression after their surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old.
I am having lumbar surgery for degenerative disc disease or spinal stenosis.
My Montreal Cognitive Assessment (MoCA) score is 18 or higher.
I can use a keyboard.
I understand and can communicate in English.
I can give my own consent.
I can confirm a negative pregnancy test if I am a woman of child-bearing age.
You may not be able to join if
I am under 18 years old.
I have a history of vagotomy.
I have a history of bradycardia or heart failure with low ejection fraction.
My Montreal Cognitive Assessment (MoCA) score is below 18.
I have a history of seizure disorder or bleeding in the brain.
I have carotid stenosis.
I am pregnant or breastfeeding.
I have a severe psychiatric disorder.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study will examine whether noninvasive, transcutaneous vagal nerve stimulation (tcVNS) can help restore consciousness in patients in the operating room and the Post Anesthesia Care Unit (PACU). The study will also investigate if tcVNS can expedite discharge from the PACU and examine whether tcVNS administerd in the PACU helps reduce delirium and depression after surgery. The study will also e…
This study will examine whether noninvasive, transcutaneous vagal nerve stimulation (tcVNS) can help restore consciousness in patients in the operating room and the Post Anesthesia Care Unit (PACU). The study will also investigate if tcVNS can expedite discharge from the PACU and examine whether tcVNS administerd in the PACU helps reduce delirium and depression after surgery. The study will also evaluate whether tcVNS speeds cognitive recovery from emergence of anesthesia and surgery.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Aged \> 18 years of age
2. Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels
3. Montreal Cognitive Assessment (MoCA) score ≥ 18 - accept mild
4. Ability to use a keyboard
5. Able to understand and communicate in E…
Inclusion Criteria:
1. Aged \> 18 years of age
2. Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels
3. Montreal Cognitive Assessment (MoCA) score ≥ 18 - accept mild
4. Ability to use a keyboard
5. Able to understand and communicate in English
6. Be able to consent independently
7. Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study.
8. Must not be involved in any other research intervention study testing neurobehavioral functioning
Exclusion Criteria:
1. Age \< 18 years of age
2. History of vagotomy (cutting the vagus nerve)
3. History of bradycardia, heart block, prolonged QT syndrome, brugada syndrome, heart failure with ejection fraction less than 35% and/or New York Heart Association symptoms
4. MoCA \< 18
5. History of seizure disorder or intracranial hemorrhage
6. Patients with carotid stenosis
7. Patients with aneurysms
8. Other neurological diagnoses or a diagnosis of severe psychiatric disorder (e.g., psychosis) or a reported childhood learning disability
9. Pregnancy, breastfeeding
10. Active addiction history
11. ECG adhesive allergy
12. Severe aphasia, preventing subject from understanding the protocol and giving written consent
13. Patients will be excluded postoperatively if there is neck swelling at the proposed site of left tcVNS.
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